2-5toWin Study

Study Name

2-5 Intermittent Caloric Restriction for Weight Loss and Insulin Resistance in HIV-Infected Adults with Features of the Metabolic Syndrome .

Study Number

18-I-0075

Goal of Study

The NIH is conducting a research study for people living with HIV and on HIV medications.  The purpose of this research study is to see if intermittent caloric restriction (ICR) leads to weight loss and improved blood sugar in obese people infected with human immunodeficiency virus (HIV). We want to find out if ICR is an effective alternative to traditional diets. 

Study Regimen

A total of 50 individuals between the ages of 18-65 are expected to participate in this study.  All participants will receive standard counselling on a healthy diet and lifestyle. Subjects will then be randomly assigned (like a flip of a coin) to either a 12-week ICR diet plan or the 12-week standard diet. All individuals in both study groups will receive American Heart Association dietary counseling, lifestyle and physical activity counseling, and a pedometer to measure daily steps and instructions for use. Subjects who enter the study will complete 8-10 study visits over a period of approximately 7 months.  Your study visits will be at the NIH Clinical Center in Bethesda, Maryland.  Study procedures include physical exams, blood draws, ultrasound and a glucose tolerance test.  Volunteers will be compensated.

Eligibility Criteria

  • You are 18-65 years old and living with HIV
  • You have taken HIV medications continuously for at least one year
  • You have a CD4 (t-cell) count over 200 at screening
  • You have an undetectable HIV viral load at screening 
  • Your Body Mass Index (BMI) is greater than 30
  • If male, your waist size is at least 40 inches; if female, it is at least 34 inches 
  • You are not currently on weight loss medication
  • You have not had weight loss surgery
  • You do not have diabetes
  • If female, you are not breastfeeding, pregnant, or trying to become pregnant

 

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